R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios, M Richardet, H Gurney, E R Kessler, Y Tomita, J Bedke, C Scheffold, M Askelson, J Panzica, J Zhang, M van Kooten Losio, T K Choueiri
{"title":"纳武单抗联合卡博赞替尼治疗晚期肾细胞癌的最终分析来自随机III期CheckMate 9ER试验。","authors":"R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios, M Richardet, H Gurney, E R Kessler, Y Tomita, J Bedke, C Scheffold, M Askelson, J Panzica, J Zhang, M van Kooten Losio, T K Choueiri","doi":"10.1016/j.annonc.2025.09.006","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial. We report final, updated efficacy and safety results with median follow-up of 5.6 years.</p><p><strong>Patients and methods: </strong>Patients with advanced RCC were randomized to first-line NIVO 240 mg IV every 2 weeks plus CABO 40 mg PO QD or SUN 50 mg PO QD (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety.</p><p><strong>Results: </strong>Median (range) follow-up was 5.6 years (67.6 [60.2-80.2] months). In intent-to-treat patients (NIVO+CABO, n=323; SUN, n=328), PFS favored NIVO+CABO versus SUN (hazard ratio [HR], 0.58 [95% CI, 0.49-0.70]). Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR, 0.79 [95% CI, 0.65-0.96]). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response, 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO versus SUN was 22.0% versus 10.0%. In all treated patients (n=320 each arm), any-grade (grade 3-4) treatment-related adverse events occurred in 97.5% (67.8%) versus 93.1% (55.0%) with NIVO+CABO versus SUN, respectively. No new deaths due to study drug toxicity occurred since the 32.9-month median follow-up.</p><p><strong>Conclusions: </strong>Long-term efficacy benefit was observed with NIVO+CABO over SUN in this final follow-up from CheckMate 9ER and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial.\",\"authors\":\"R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios, M Richardet, H Gurney, E R Kessler, Y Tomita, J Bedke, C Scheffold, M Askelson, J Panzica, J Zhang, M van Kooten Losio, T K Choueiri\",\"doi\":\"10.1016/j.annonc.2025.09.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial. We report final, updated efficacy and safety results with median follow-up of 5.6 years.</p><p><strong>Patients and methods: </strong>Patients with advanced RCC were randomized to first-line NIVO 240 mg IV every 2 weeks plus CABO 40 mg PO QD or SUN 50 mg PO QD (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety.</p><p><strong>Results: </strong>Median (range) follow-up was 5.6 years (67.6 [60.2-80.2] months). In intent-to-treat patients (NIVO+CABO, n=323; SUN, n=328), PFS favored NIVO+CABO versus SUN (hazard ratio [HR], 0.58 [95% CI, 0.49-0.70]). Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR, 0.79 [95% CI, 0.65-0.96]). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response, 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO versus SUN was 22.0% versus 10.0%. In all treated patients (n=320 each arm), any-grade (grade 3-4) treatment-related adverse events occurred in 97.5% (67.8%) versus 93.1% (55.0%) with NIVO+CABO versus SUN, respectively. No new deaths due to study drug toxicity occurred since the 32.9-month median follow-up.</p><p><strong>Conclusions: </strong>Long-term efficacy benefit was observed with NIVO+CABO over SUN in this final follow-up from CheckMate 9ER and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.</p>\",\"PeriodicalId\":8000,\"journal\":{\"name\":\"Annals of Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":65.4000,\"publicationDate\":\"2025-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.annonc.2025.09.006\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.annonc.2025.09.006","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial.
Background: Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial. We report final, updated efficacy and safety results with median follow-up of 5.6 years.
Patients and methods: Patients with advanced RCC were randomized to first-line NIVO 240 mg IV every 2 weeks plus CABO 40 mg PO QD or SUN 50 mg PO QD (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety.
Results: Median (range) follow-up was 5.6 years (67.6 [60.2-80.2] months). In intent-to-treat patients (NIVO+CABO, n=323; SUN, n=328), PFS favored NIVO+CABO versus SUN (hazard ratio [HR], 0.58 [95% CI, 0.49-0.70]). Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR, 0.79 [95% CI, 0.65-0.96]). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response, 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO versus SUN was 22.0% versus 10.0%. In all treated patients (n=320 each arm), any-grade (grade 3-4) treatment-related adverse events occurred in 97.5% (67.8%) versus 93.1% (55.0%) with NIVO+CABO versus SUN, respectively. No new deaths due to study drug toxicity occurred since the 32.9-month median follow-up.
Conclusions: Long-term efficacy benefit was observed with NIVO+CABO over SUN in this final follow-up from CheckMate 9ER and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.
期刊介绍：
Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine.
The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings.
Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.
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